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Empower Professionals - Foster City, CA
posted about 1 month ago
About the position
The Validation Engineer role is focused on ensuring compliance and validation of computerized systems within an FDA regulated environment. The position involves authoring and revising critical documentation related to GxP systems, executing validation protocols, and collaborating with cross-functional teams to maintain system integrity and compliance. The role requires a strong understanding of regulatory requirements and validation methodologies, particularly in relation to environmental monitoring systems.
Responsibilities
- Author and/or revise documents related to GxP Systems, including User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, and Installation, Operational and Performance Qualification protocols.
- Execute authored protocols for validation processes.
- Author change management records and revise impacted documentation, executing change implementation tasks.
- Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems.
- Collaborate with cross-functional teams in authoring CAPAs and Deviations.
- Perform periodic system maintenance activities such as account management, system maintenance, system audit trail review, and backup and restore testing.
- Maintain system-specific operational documentation including SOPs, work instructions, and training plans, and contribute to the authoring and maintenance of business SOPs.
- Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management.
- Align with business stakeholders to deliver technical and compliant solutions as required.
- Coordinate with software vendors for change deployment, scheduling of system maintenance activities, and issue management.
Requirements
- Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems.
- Experience in computer system validation using GAMP 5 methodology.
- Good understanding of 21 CFR part 11 and Annex 11 as they relate to environmental monitoring systems.
- Experience in developing validation methodology for global implementation of systems.
- Familiarity with validation methodologies and SDLC best practices.
- Proficient in current Good Manufacturing Practices (cGMPs) requirements.
Nice-to-haves
- Technical proficiency in Process Control Systems / Environmental Monitoring Systems.
- Data Migration experience.
- Project Management experience.
